Trial conducted to check Assessment of safety and efficacy for COPD patients. The patients will be on once daily treatment of tiotropium plus olodaterol fixed dose combination inhalation solution delivered by the Respimat® inhaler
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disorder
- Registration Number
- CTRI/2012/04/002554
- Lead Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 2500
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior
to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of COPD [P10-01267] and must meet the
following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator
FEV1 < 80% of predicted normal (ECSC, [R94-1408]; GOLD II - IV, [P10-01267] and
a post-bronchodilator FEV1/FVC <70% at Visit 1 (See Appendix 10.3 for ECSC
predicted normal equations).
3. Male or female patients, 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack
years. (see Appendix 10.3 for calculation):
Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to
• perform technically acceptable pulmonary function tests ,
• perform technically acceptable PEF measurements,
• maintain records (Patient Daily e-Diary) during the study period ,
• perform all other assessments (e.g. complete self administed questionnaires),
as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the
RESPIMAT inhaler
Patients with a significant disease other than COPD
Patients with a history of asthma.
A diagnosis of thyrotoxicosis
A diagnosis of paroxysmal tachycardia (100 beats per minute) (due to the known class side effect profile of Ã?2-agonists).
A history of myocardial infarction within 1 year of screening visit (Visit 1).
Unstable or life-threatening cardiac arrhythmia.
Hospitalization for heart failure within the past year.
Patients who regularly use daytime oxygen therapy for more than one hour per day
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
Pregnant or nursing women.
Women of childbearing potential not using a highly effective method of birth control.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ FEV1 AUC0-3h response <br/ ><br>â?¢ Trough FEV1 response <br/ ><br>â?¢ SGRQ (total score) (Combined data from 1237.5 and1237.6) <br/ ><br>Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method The TDI focal score (to measure the effect of tiotropium plus olodaterol combination on patientsâ?? health-related quality of life) is key secondary endpoint (Combined data from 1237.5 and1237.6) <br/ ><br>Timepoint: 24 weeks